BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103696 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25437
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO NUMBERS SCROLLING UP NOTED. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD SCROLLING NUMBERS DURING A BOLUS ATTEMPT. THE CUSTOMER REPLACED THE BATTERY AND RECEIVED A FAILED BATTERY TEST. THE BLOOD GLUCOSE READING WAS 210 MG/DL. SHE STATED THAT WHEN SHE PRESSED THE B BUTTON TO PERFORM A BOLUS, THE NUMBERS KEPT SCROLLING WITHOUT STOPPING, AND THAT SHE WAS UNABLE TO EXIT THE LOOP. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582283 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR